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High level readout:Expression of Interest for supply of COVID-19 vaccines

General public version, 5 August 2020

Expression of Interest (EOI) overview

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UNICEF issued an EOI on 15 June 2020 on behalf of COVAX to vaccine developers / manufacturers. Information provided and compiled as of 1 July 2020.

• EOI Objectives: Understand manufacturing plans and help inform design elements of COVAX and procurement approach

• Information requested:o Production volumeso Manufacturing platformso Timing of availabilityo Product presentationo Pricing policyo Support needed (e.g. on licensure pathway, registration…)

26 respondents to EOI

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Anhui Zhifei LongcomBiopharmaceuticalsAstrazenicaAurobindo Pharma LimitedBeijing BiominhaiBeijing Institute of Biological ProductsBharat Biotech International LimitedBiological E LimitedChengduChumakovFSUEGSKIndian ImmunologicalJanssenMerck MSDNingBo RongAn Biological MedicineNovavaxPanacea BiotecPfizerSanofi Pasteur Shionogi & Co.Serum Institute of IndiaSinocelltechSinovacSK BioscienceStemirna TherapeuticsTakedaWalvax BiotechnologyWuhan

• 10 with manufacturing in China• 6 in India• 3 in the USA• 2 in each of Belgium, Russia, Japan• 1 in each of France, S. Korea, Switzerland and the UK

How much vaccine is needed globally?

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•Global vaccine demand depends on how long immunity lasts, the effectiveness of the vaccine & the number of doses per vaccine course (assumption is 2 doses per course)•The ACT-A goal is to secure “2 billion doses by 2021”•WHO is developing a frameworkto allocate Covid-19 vaccines. The current draft allocates as follows:•Every country receives doses for 3% of their population to reach health and social care workers with an immunisation course•Then, every country receives second allocation for up to 20% of their population to reach people over the age of 65 and people at higher risk of critical Covid-19 disease due to underlying conditions• Combined, these amounts exceed the 2 billion dose target for ACT if we assume they are needed prior to end 2021. The higher of the two volumes was used.

Global indicated volumes compared with global demand scenario

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Global demand scenario, annual vaccination

By end 2020: 110 millionBy end 2021: 5.4 billionBy end 2022: 15.8 billionBy end 2023: 15.8 billion

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Volumes from other175+ candidates in pipeline not included.

Number of doses available, as indicated in EOI or publicly stated (NB: Data unqualified)

By end 2020: 1.3 billionBy June 2021: 1.8 billionBy end 2021: 7.4 billionBy end 2022: 13.5 billionBy end 2023: 14.1 billion

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Global Base case supply vs. Base case demand

Projected annual manufacturing volumes from manufacturers with or without another WHO prequalified vaccine

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Projected annual manufacturing quantities by location of manufacturing

• In 2020, 19% are from mfrs in China; 22% are from mfrs in India• In 2023, 49% are from China; 22% from India

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Vaccine platform In 2020/2021, volumes spread across platforms by 2022/2023, protein subunit candidates account for majority of volumes indicated

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Risks and support identified by manufacturersRegulatory pathway, country licensing, indemnity, clinical trials, COVAX design

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• Streamlining / harmonizing regulatory processes at national and global level

• Accelerated PQ process (ref lessons learned from Ebola)

• Creation of an emergency use pathway

• Support to in-country registration

• Consultation with industry on mechanisms & processes

• Information on what type of support is available to manufacturers & when

• Communication & consultation with industry on demand, programmatic policy & approaches

• Support for enrolment in phase 3 clinical trials (esp outside of China)

• Data sharing / cooperation between clinical trials

• Clarification on minimum level of acceptance for Phase III clinical trials

• More information and dialogue on product presentation

• Acceptance of universal packaging in English with country specific inserts in tertiary packaging

• Technical matchmaking (company) specific

• Push/pull funding for adjuvants, fill/finish capacity

• Adjuvant matchmaking

• Validation of country readiness

• Consultation with industry on CCE requirements

Vaccine specifications [NB: Most information just indicative]

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• All liquid except some freeze-dried products (Freeze dried can be more stable but require another manufacturing step; i.e. slower to scale; and more room for administration error)

• All indicated intramuscular injection, except one nasal atomisation

• Majority indicated 2-dose course, a few indicated single dose, one indicated single dose with booster, one indicated 3-dose course

• Majority indicated vaccine would be provided in a multi-dose vial• Number of doses per via to be decided (8) – >50 doses per container (2)• A plan for vial size - 1, 2, 5 or 10 (6)• Pre-filled syringe (5)

• Most have target temperature requirement of stability between 2oC and 8oC.

But stability data takes time … so could expect minus (-60oC) temperature requirement and shorter shelf life during 2020-2021

Will a COVID-19 vaccine be a silver bullet?

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• Indications of global vaccine production is positive.

• The impact of a vaccine depends on how long immunity lasts and the effectiveness of the vaccine

• Likely to be different vaccines with different efficacy, different durations of protection, different and presentations

• Short duration and modest effectiveness may imply booster vaccination or annual vaccination

• The development of an antiviral medicine remains important. Most therapeutic research is currently around monoclonal antibodies/plasma – which is hard to scale, especially in low resource countries.

“We think that it will protect for about a year” AstraZeneca CEO

“The durability of immunity [to common coronaviruses] that is protective, ranges from 3 to 6 months to almost always less than 1 year”Director, NIH, A. Fauci

50% effective: the WHO and FDA

minimum standard for COVID-19 Vx

Key Messages

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Overall, including given the volumes not included, the supply situation could not be more optimistic in terms of massive scale up of Covid-19 vaccine.

Unprecedented rapid pursuit for discovery and scale-up of a vaccine. Reducing what would normally take 10-20 years to potentially 1-3 years

The vaccine portfolio has a good mix of platforms, manufacturing locations and partnerships

Quantities in 2020-2021 will be tight. Demand allocation will be key to maximise impact (country readiness, basis for allocation, etc.)

It could be reasonable to assume that a vaccine will be available for widespread roll-out starting in late 2022; likely that annual vaccination or booster will be needed

Potential high dependency on manufacturers that have never taken a vaccine through WHO PQ

Manufacturers need support and clear pathways on what could be major bottlenecks to supply

• WHO emergency use listing (especially in the context of large array of platforms)• Country licensure and registration requirements• Liability and indemnification

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Thank You

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For questions or more information, please contact:

Gian GandhiCOVAX CoordinatorOffice of the Director, UNICEF Supply Divisionggandhi@unicef.org

Yalda MomeniSenior COVAX Contracts ManagerVaccine Centre, UNICEF Supply Divisionymomeni@unicef.org